Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Cervarix
Human Papillomavirus (HPV) 16 L1 Protein 20mcg
Human Papillomavirus (HPV) 18 L1 Protein 20mcg
Suspension for injection
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals SA, Wavre, Belgium
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Kalydeco
Ivacaftor 150mg
Film coated tablet
Novotech (New Zealand) Limited
Patheon Pharmaceuticals Inc, Ohio, United States of America
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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RIXUBIS
Nonacog gamma 50IU/mL equivalent to 250IU/vial
Powder for injection with diluent
Baxalta New Zealand Limited
Baxter Healthcare Corporation, California, United States of America
Hameln Pharmaceuticals GmbH, Hameln, Germany
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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RIXUBIS
Nonacog gamma 100IU/mL equivalent to 500IU/vial
Powder for injection with diluent
Baxalta New Zealand Limited
Baxter Healthcare Corporation, California, United States of America
Hameln Pharmaceuticals GmbH, Hameln, Germany
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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RIXUBIS
Nonacog gamma 200IU/mL equivalent to 1000IU/vial
Powder for injection with diluent
Baxalta New Zealand Limited
Baxter Healthcare Corporation, California, United States of America
Hameln Pharmaceuticals GmbH, Hameln, Germany
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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RIXUBIS
Nonacog gamma 400IU/mL equivalent to 2000IU/vial
Powder for injection with diluent
Baxalta New Zealand Limited
Baxter Healthcare Corporation, California, United States of America
Hameln Pharmaceuticals GmbH, Hameln, Germany
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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RIXUBIS
Nonacog gamma 600IU/mL equivalent to 3000IU/vial
Powder for injection with diluent
Baxalta New Zealand Limited
Baxter Healthcare Corporation, California, United States of America
Hameln Pharmaceuticals GmbH, Hameln, Germany
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Dated this 8th day of January 2016.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz